CLCZ696B2319E1 OL Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With HF

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03785405
Collaborator
(none)
240
Enrollment
74
Locations
1
Arm
44
Anticipated Duration (Months)
3.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate long-term safety and tolerability data in eligible CLCZ696B2319 (PANORAMA-HF) patients receiving open-label sacubitril/valsartan.

Condition or DiseaseIntervention/TreatmentPhase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
240 participants
Allocation:
N/A
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter Study to Evaluate Long-term Safety and Tolerability of Open Label Sacubitril/Valsartan in Pediatric Patients With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction Who Have Completed Study CLCZ696B2319
Actual Study Start Date :
May 2, 2019
Anticipated Primary Completion Date :
Apr 21, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: sacubitril/valsartan

single arm, open label sacubitril/valsartan

Drug: sacubitril/valsartan
Target dose 3.1 mg/kg bid Formulations: Tablets (50, 100, 200 mg) Granules [12.5 mg (4 granules), 31.25 mg (10 granules), in capsules] Liquid (1 mg/ml, 4 mg/ml, prepared from tablets)
Other Names:
  • LCZ696
  • Outcome Measures

    Primary Outcome Measures

    1. Number of participants with Adverse Events (AEs) as a measure of safety and tolerability [to end of study, up to 3 years]

      Safety. Assessments include: Adverse Events (AEs)

    2. Number of participants with Serious Adverse Events (SAEs) as a measure of safety and tolerability [to end of study, up to 3 years]

      Safety. Assessments include: Serious Adverse Events (SAEs)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Signed informed consent

    • On study drug at PANORAMA-HF Part 2 EOS visit. Does not have any significant safety issue

    Exclusion Criteria:
    • Subject only participated in PANORAMA-HF Part 1 or was a SF in PANORAMA-HF or permanently discontinued study drug in PANORMA-HF Part 2

    • Use of investigational drugs within 5 half-lives of enrollment or within 30 days (longer duration); with the exception of PANORAMA-HF study drug (requires >/=36-hour washout before baseline visit)

    • History of hypersensitivity or allergy to study treatment, its excipients or drugs of similar chemical class, ACEIs, ARBs, or NEP inhibitor and known/suspected contraindications to sacubitril/valsartan

    • Renal vascular hypertension (including renal artery stenosis)

    • Significant renal estimated glomerular filtration rate disorder (eGFR calculated using modified Schwartz formula <30% mean GFR for age); hepatic disorder (serum aspartate aminotransferase or alanine aminotransferase > 3 times upper limit of normal); gastrointestinal disorder or biliary disorder

    • History of angioedema

    • Parents or legal guardians of subject who do not give consent or allow the child to give assent, or inability of patient or parents/legal guardians to follow instructions or comply with follow-up procedures

    • Any medical condition(s) that may put the patient at risk in the investigator's opinion or that the investigator deems unsuitable for the study

    • Other protocol defined inclusion/exclusion criteria may apply

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Novartis Investigative SiteLoma LindaCaliforniaUnited States92354
    2Novartis Investigative SiteLos AngelesCaliforniaUnited States90095
    3Novartis Investigative SitePalo AltoCaliforniaUnited States94304
    4Novartis Investigative SiteHollywoodFloridaUnited States33021
    5Novartis Investigative SiteSaint PetersburgFloridaUnited States33701
    6Novartis Investigative SiteAtlantaGeorgiaUnited States30322
    7Novartis Investigative SiteIndianapolisIndianaUnited States46202
    8Novartis Investigative SiteBostonMassachusettsUnited States02115
    9Novartis Investigative SiteAnn ArborMichiganUnited States48109-5238
    10Novartis Investigative SiteMinneapolisMinnesotaUnited States55455
    11Novartis Investigative SiteRochesterMinnesotaUnited States55905
    12Novartis Investigative SiteSaint LouisMissouriUnited States63110
    13Novartis Investigative SiteNew YorkNew YorkUnited States10032
    14Novartis Investigative SiteCharlotteNorth CarolinaUnited States28203
    15Novartis Investigative SitePhiladelphiaPennsylvaniaUnited States19104
    16Novartis Investigative SitePittsburghPennsylvaniaUnited States15224
    17Novartis Investigative SiteCiudad de SaltaProvincia De SaltaArgentinaA4406BPF
    18Novartis Investigative SiteInnsbruckAustria6020
    19Novartis Investigative SiteSofiaBulgaria1309
    20Novartis Investigative SiteEdmontonAlbertaCanadaT6G 1C9
    21Novartis Investigative SiteTorontoOntarioCanadaM5G 1X8
    22Novartis Investigative SiteZagrebCroatia10000
    23Novartis Investigative SitePraha 5Czechia150 06
    24Novartis Investigative SiteHelsinkiFinland00290
    25Novartis Investigative SiteParisFrance75015
    26Novartis Investigative SiteFreiburgGermany79106
    27Novartis Investigative SiteHeidelbergGermany69120
    28Novartis Investigative SiteBudapestHungaryH 1096
    29Novartis Investigative SiteNew DelhiDelhiIndia110076
    30Novartis Investigative SiteAhmedabadGujaratIndia380 060
    31Novartis Investigative SiteKochiKeralaIndia682041
    32Novartis Investigative SiteNew DelhiIndia110029
    33Novartis Investigative SiteBe'er-ShevaIsrael84101
    34Novartis Investigative SiteBergamoBGItaly24127
    35Novartis Investigative SiteBolognaBOItaly40138
    36Novartis Investigative SiteFirenzeFIItaly50132
    37Novartis Investigative SiteMilanoMIItaly20162
    38Novartis Investigative SiteRomaRMItaly00165
    39Novartis Investigative SiteTorinoTOItaly10126
    40Novartis Investigative SiteNapoliItaly80131
    41Novartis Investigative SiteObuAichiJapan474 8710
    42Novartis Investigative SiteSapporo cityHokkaidoJapan060 8648
    43Novartis Investigative SiteOmuraNagasakiJapan856-8562
    44Novartis Investigative SiteBunkyo kuTokyoJapan113 8655
    45Novartis Investigative SiteShinjuku kuTokyoJapan162 8666
    46Novartis Investigative SiteToyama-cityToyamaJapan930-0194
    47Novartis Investigative SiteYangsan SiGyeongsangnam DoKorea, Republic of50612
    48Novartis Investigative SiteSeoulKorea, Republic of03080
    49Novartis Investigative SiteSeoulKorea, Republic of03722
    50Novartis Investigative SiteSeoulKorea, Republic of06351
    51Novartis Investigative SiteAshrafiehLebanon166830
    52Novartis Investigative SiteBeirutLebanon
    53Novartis Investigative SiteWarszawaPoland04 730
    54Novartis Investigative SiteWroclawPoland51-124
    55Novartis Investigative SiteCarnaxideLisboaPortugal2799 523
    56Novartis Investigative SiteCoimbraPortugal3000 075
    57Novartis Investigative SiteLisboaPortugal1169 024
    58Novartis Investigative SiteMoscowRussian Federation125412
    59Novartis Investigative SiteSaint PetersburgRussian Federation197341
    60Novartis Investigative SiteSingaporeSingapore119260
    61Novartis Investigative SiteSingaporeSingapore229899
    62Novartis Investigative SiteSowetoGautengSouth Africa2013
    63Novartis Investigative SiteCordobaAndaluciaSpain14004
    64Novartis Investigative SiteBarcelonaCatalunaSpain08950
    65Novartis Investigative SiteBarcelonaCatalunyaSpain08035
    66Novartis Investigative SiteMadridSpain28046
    67Novartis Investigative SiteLausanneSwitzerland1011
    68Novartis Investigative SiteTainanTaiwan70403
    69Novartis Investigative SiteTaipeiTaiwan10041
    70Novartis Investigative SiteBangkoknoiBangkokThailand10700
    71Novartis Investigative SiteBangkokThailand10400
    72Novartis Investigative SiteAnkaraTurkey06490
    73Novartis Investigative SiteIzmirTurkey35040
    74Novartis Investigative SiteKonak/IzmirTurkey35210

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT03785405
    Other Study ID Numbers:
    • CLCZ696B2319E1
    First Posted:
    Dec 24, 2018
    Last Update Posted:
    Oct 7, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Novartis Pharmaceuticals
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 7, 2021